Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 272 for:    Betamethasone

Betamethasone and Severity of Hyaline Membrane Disease (b-Mhyalines)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854840
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

Condition or disease
Pregnant Women Receive Celesten

Detailed Description:
β-Mhyalines is a prospective multicentric non interventional study. One hundred fifty pregnant women at risk of premature delivery, in the framework of Hyaline Membrane Disease of the neonate, will receive 2 intramuscular injections of Celesten (betamethasone) at 24 hours interval. Plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. Concentrations will be measured and analyzed using a population approach. A ratio between neonatal and maternal exposure will be calculated to represent placental transfer. The effect of covariates (genetic polymorphism for CYP3A4, CYP3A5, P-glycoprotein…, and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. The relationship between placental transfer and the occurrence and severity of the Hyaline Membrane Disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of Hyaline Membrane Disease.

Layout table for study information
Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature
Actual Study Start Date : January 12, 2012
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : December 31, 2018


Group/Cohort
Celesten in prevention of hyaline membrane disease.
Pregnant women that received at least a first injection of Celesten in the prevention of hyaline membrane disease.



Primary Outcome Measures :
  1. Number of neonates with hyaline membrane disease [ Time Frame: 3 days ]
    respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology


Secondary Outcome Measures :
  1. Genetic polymorphisms [ Time Frame: Day 1 ]
    To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein)

  2. mode of delivery [ Time Frame: Day 7 ]
    To study the variability of the factor " mode of delivery" on fetal morbidity

  3. blood sample of betamethasone [ Time Frame: Day 1 and day 2 ]
    To study the pharmacokinetics of betamethasone in all women treated

  4. Optimal dose of betamethasone [ Time Frame: Day 28 ]
    Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks

  5. gestational age [ Time Frame: Day 7 ]
    To study the variability of the factors "gestational age" on fetal morbidity

  6. birth weight [ Time Frame: Day 7 ]
    To study the variability of the factor " birth weight" on fetal morbidity

  7. sex [ Time Frame: Day 7 ]
    To study the variability of the factor "sex" on fetal morbidity

  8. Apgar score [ Time Frame: Day 7 ]
    To study the variability of the factor " Apgar score " on fetal morbidity

  9. twinning [ Time Frame: Day 7 ]
    To study the variability of the factors "twinning" on fetal morbidity

  10. time between birth and the last dose [ Time Frame: Day 7 ]
    To study the variability of the factor "time between birth and the last dose" on fetal morbidity

  11. ethnicity [ Time Frame: Day 7 ]
    To study the variability of the factor "ethnicity" on fetal morbidity

  12. maternal disease and treatment [ Time Frame: Day 7 ]
    To study the variability of the factor " maternal disease and treatment on fetal morbidity


Biospecimen Retention:   Samples With DNA
Plasma samples will be collected. The effect of covariates as genetic polymorphism for CYP3A4, CYP3A5 and P-glycoprotein will be tested to explain the variability of placental transfer


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women (at one-term >27 PMA) that received at least a first injection of Celesten in the prevention of hyaline membrane disease
Criteria

Inclusion Criteria:

  • Pregnant women who received at least a first injection of Celesten in the prevention of MMH.
  • A one-term> 27 SA,
  • Major Patients > or = 18 years old
  • Informed Consent Form signed

Exclusion Criteria:

  • Patients undergoing treatment with corticosteroids in the long term

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854840


Locations
Layout table for location information
France
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Yves Ville, MD, PhD Necker Hospital

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01854840     History of Changes
Other Study ID Numbers: NI10069
2011-A01257-34 ( Other Identifier: AFSSAPS )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
hyaline membrane disease
placenta
betamethasone
Additional relevant MeSH terms:
Layout table for MeSH terms
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Hyaline Membrane Disease
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents